The following data is part of a premarket notification filed by Avanced Orthopaedic Solutions, Inc. (aos) with the FDA for Aos Small Fragment Plating System.
Device ID | K152732 |
510k Number | K152732 |
Device Name: | AOS Small Fragment Plating System |
Classification | Plate, Fixation, Bone |
Applicant | AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) 3203 KASHIWA STREET Torrance, CA 90505 |
Contact | Mark Steinhauer |
Correspondent | Mark Steinhauer AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) 3203 KASHIWA STREET Torrance, CA 90505 |
Product Code | HRS |
Subsequent Product Code | HTN |
Subsequent Product Code | HWC |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-22 |
Decision Date | 2015-12-10 |
Summary: | summary |